Recall of Philips Healthcare MX 16slice CT Scanner System and MX 16slice CT Scanner System Phase 11

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Medical Systems (Cleveland) Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69473
  • Event Risk Class
    Class 2
  • Event Number
    Z-0190-2015
  • Event Initiated Date
    2014-10-09
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2015-07-02
  • Event Source
    USFDA
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, x-ray, tomography, computed - Product Code JAK
  • Reason
    "the orientation of images is displayed incorrectly. when operator chooses gantry on the right side from operation console, and the patient position is hfdl, hfdr, ffdl or ffdr, the patient position picture and text is not consistent. "l" and "r" of scan images are reversed and this is not consistent with the patient actual position. "when a surview which is longe.
  • Action
    Philips is informing the consignees of this issue through a Field Safety Notice (FSN) 72800615 on October 09, 2014. The US consignees will receive this notice via certified mail and Philips Key Market representatives will distribute the FSN internationally. Additionally, A Field Service Engineer will contact each site to schedule a time to install the software update.

Device

  • Model / Serial
    Model Number: 728131, Serial Number(s):  EP16E090001,EP16E090002,EP16E090003,EP16E090004,EP16E090006,EP16E090007,EP16E090008, EP16E090009,EP16E090010,EP16E090011,EP16E090012,EP16E090013,EP16E090015,EP16E100001, EP16E100004,EP16E100005,EP16E100006,EP16E100007,EP16E100008,EP16E100010,EP16E100011, EP16E100012,EP16E100013,EP16E100015,EP16E100016,EP16E100017,EP16E100018, EP16E100019,EP16E100020,EP16E100021,EP16E100022,EP16E100023,EP16E100024,EP16E100025, EP16E100026,EP16E100027,EP16E100028,EP16E100029,EP16E100030,EP16E100031,EP16E100032, EP16E100033,EP16E100034,EP16E100035,EP16E100036,EP16E100037,EP16E100038,EP16E100039, EP16E100041,EP16E100043,EP16E100044,EP16E100045,EP16E100046,EP16E100047,EP16E100048, EP16E100049,EP16E100051,EP16E100052,EP16E100055,EP16E100056,EP16E100057,EP16E100058, EP16E100059,EP16E100060,EP16E100061,EP16E100062,EP16E100063,EP16E100067,EP16E100069, EP16E100070,EP16E100071,EP16E100072,EP16E100073,EP16E100074,EP16E100075,EP16E100076, EP16E100077,EP16E100078,EP16E100079,EP16E100080,EP16E100081,EP16E100082,EP16E100083, EP16E100084,EP16E100085,EP16E100086,EP16E100087,EP16E100088,EP16E100090,EP16E100091, EP16E100092,EP16E100093,EP16E100094,EP16E100095,EP16E100096,EP16E100099,EP16E100100, EP16E100101,EP16E100102,EP16E100103,EP16E100104,EP16E100105,EP16E100106,EP16E100107, EP16E100108,EP16E100109,EP16E100110,EP16E100111,EP16E100112,EP16E100113,EP16E110003, EP16E110005,EP16E110006,EP16E110007,EP16E110009,EP16E110011,EP16E110012,EP16E110013, EP16E110014,EP16E110015,EP16E110017,EP16E110018,EP16E110019,EP16E110020,EP16E110021, EP16E110023,EP16E110024,EP16E110025,EP16E110026,EP16E110027,EP16E110028,EP16E110029, EP16E110030,EP16E110031,EP16E110032,EP16E110033,EP16E110034,EP16E110035,EP16E110037, EP16E110038,EP16E110039,EP16E110042,EP16E110043,EP16E110044,EP16E110045,EP16E110046, EP16E110047,EP16E110048,EP16E110049,EP16E110050,EP16E110051,EP16E110052,EP16E110054, EP16E110055,EP16E110056,EP16E110057,EP16E110058,EP16E110060,EP16E110062,EP16E110063, EP16E110064,EP16E110066,EP16E110067,EP16E110069,EP16E110070,EP16E110074,EP16E110075, EP16E110077,EP16E110078,EP16E110083,EP16E110085,EP16E110089,EP16E110090,EP16E110091, EP16E110092,EP16E110093,EP16E110095,EP16E110096,EP16E110097,EP16E110099,EP16E110100, EP16E110101,EP16E110102,EP16E110104,EP16E110105,EP16E110106,EP16E110108,EP16E110109, EP16E110110,EP16E110111,EP16E110115,EP16E110117,EP16E110118,EP16E110119,EP16E120003, EP16E120004,EP16E120005,EP16E120006,EP16E120007,EP16E120008,EP16E120009,EP16E120010, EP16E120011,EP16E120014,EP16E120015,EP16E120016,EP16E120017,EP16E120019,EP16E120021, EP16E120023,EP16E120024,EP16E120025,EP16E120026,EP16E120027,EP16E120029,EP16E120030, EP16E120031,EP16E120032,EP16E120033,EP16E120034,EP16E120035,EP16E120036,EP16E120037, EP16E120039,EP16E120041,EP16E120042,EP16E120043,EP16E120044,EP16E120045,EP16E120046, EP16E120047,EP16E120048,EP16E120050,EP16E120051,EP16E120052,EP16E120054,EP16E120055, EP16E120056,EP16E120058,EP16E120059,EP16E120060,EP16E120061,EP16E120063,EP16E120065, EP16E120067,EP16E120070,EP16E120071,EP16E120072,EP16E120074,EP16E120075,EP16E120076, EP16E120078,EP16E120081,EP16E120083,EP16E120088,EP16E120090,EP16E120091,EP16E120092, EP16E120093,EP16E120095,EP16E120096,EP16E120097,EP16E120098,EP16E120099,EP16E120100, EP16E120101,EP16E120102,EP16E120104,EP16E120105,EP16E120109,EP16E120110,EP16E120111, EP16E120113,EP16E120117,EP16E120118,EP16E120120,EP16E120121,EP16E120122,EP16E120123, EP16E120124,EP16E120125,EP16E120127,EP16E120128,EP16E120129,EP16E120130,EP16E130002, EP16E130003,EP16E130004,EP16E130005,EP16E130006,EP16E130007,EP16E130009,EP16E130010, EP16E130012,EP16E130013,EP16E130014,EP16E130015,EP16E130016,EP16E130017,EP16E130020, EP16E130021,EP16E130022,EP16E130023,EP16E130025,EP16E130026,EP16E130027,EP16E130029, EP16E130030,EP16E130031,EP16E130033,EP16E130034,EP16E130035,EP16E130036,EP16E130037, EP16E130040,EP16E130041,EP16E130042,EP16E130043,EP16E130044,EP16E130045,EP16E130046, EP16E130047,EP16E130048,EP16E130049,EP16E130050,EP16E130051,EP16E130052,EP16E130053, EP16E130055,EP16E130056,EP16E130057,EP16E130058,EP16E130062,EP16E130063,EP16E130064, EP16E130065,EP16E130066,EP16E130067,EP16E130068,EP16E130069,EP16E130070,EP16E130071, EP16E130072,EP16E130073,EP16E130074,EP16E130075,EP16E130076,EP16E130077,EP16E130078, EP16E130079,EP16E130080,EP16E130081,EP16E130082,EP16E130083,EP16E130086,EP16E130087, EP16E130088,EP16E130089,EP16E130091,EP16E130092,EP16E130093,EP16E130094,EP16E130095, EP16E130097,EP16E130098,EP16E130099,EP16E130100,EP16E130101,EP16E130102,EP16E130103, EP16E130105,EP16E130106,EP16E130107,EP16E130109,EP16E130110,EP16E140001,EP16E140002, EP16E140003,EP16E140006,EP16E140007,EP16E140008,EP16E140009,EP16E140010,EP16E140011, EP16E140012,EP16E140013,EP16E140014,EP16E140015,EP16E140016,EP16E140017,EP16E140018, EP16E140019,EP16E140021,EP16E140022,EP16E140023,EP16E140024,EP16E140025,EP16E140026, EP16E140027,EP16E140028,EP16E140029,EP16E140030,EP16E140031,EP16E140032,EP16E140033, EP16E140041,EP16EB110003,EP16EB110004,EP16EB110005,EP16EB110006,EP16EB120006, EP16EB120007, EP16EB120008, EP16EB120009, EP16EB130001, EP16EB130002, EP16EB130003, EP16EB130004, EP16EB130005, EP16EB130006, EP16EB130007, EP16EB130008, EP16EB130009, EP16EB130010, EP16EB130011, EP16EB130012, EP16EB130013, EP16EB130014, EP16EB130015, EP16EB130016, EP16EB130017, EP16EB130018, EP16EB130019, EP16EB130020, EP16EB130021, EP16EB140001, EP16EB140002, P16C080001, P16C080002, P16C100001, P16C100002, P16C100003, P16C100004, P16C100005, P16C100007, P16C100008, P16C100009, P16C100010, P16C100011, P16C100012, P16C100013, P16C100014, P16C100015, P16C100017, P16C100018, P16C110001, P16C110002, P16C110003, P16C110004, P16C110005, P16C110006, P16C110007, P16C110008, P16C110011, P16C110012, P16C110013, P16C110014, P16C110015, P16C110016, P16C110017, P16C110018, P16C110019, P16C110020, P16C110021, P16C110022, P16C110023, P16C110024, P16C110025, P16C110026, P16C110027, P16C110028, P16C110029, P16C110030, P16C110031, P16C110032, P16C110033, P16C110034, P16C110035, P16C110036, P16C110037, P16C120001, P16C120002, P16C120003, P16C120006, P16C120007, P16C120008, P16C120009, P16C120010, P16C120011, P16C120012, P16C120014, P16C120015, P16C120016, P16C120017, P16C120018, P16C120019, P16C120020, P16C120021, P16C120022, P16C120023, P16C120024, P16C120025, P16C120026, P16C120027, P16C120028, P16C120029, P16C120030, P16C120031, P16C120032, P16C120033, P16C120034, P16C120035, P16C120036, P16C120037, P16C120038, P16C120039, P16C120040, P16C120041, P16C120042, P16C120043, P16C120044, P16C120045, P16C120046, P16C120047, P16C120048, P16C120049, P16C120050, P16C120051, P16C130001, P16C130002, P16C130003, P16C130004, P16C130005, P16C130006, P16C130007, P16C130008, P16C130009, P16C130010, P16C130011, P16C130012, P16C130013, P16C130014, P16C130015, P16C130016, P16C130017, P16C130018, P16C130019, P16C130020, P16C130021, P16C130023, P16C130024, P16C130025, P16C130026, P16C130027, P16C130028, P16C130029, P16C130030, P16C130031, P16C130032, P16C130033, P16C130034, P16C130035, P16C130036, P16C130037, P16C130038, P16C130039, P16C130041, P16C130043, P16C130044, P16C130045, P16C130046, P16C130047, P16C130048, P16C130049, P16C130050, P16C130051, P16C130052, P16C130053, P16E080005, P16E080007, P16E080008, P16E090002, P16E090003, P16E090004, P16E090005, P16E090006, P16E090007, P16E090008, P16E090009, P16E090010, P16E090011, P16E090012, P16E090013, P16E090014, P16E090015, P16E090016, P16E090017, P16E090018, P16E090019, P16E090020, P16E090021, P16E090024, P16E090025, P16E090026, P16E090027, P16E090028, P16EF80010, P16EM08003, P16EM09002, P16EM09003, P16EM09004, P16EVO130002, P16EVO130003, P16EVO140001, P16EVO140002, P16EVO140003, P16EVO140005, P16EVO140006, P16EVO140007, P16EVO140008  Model Number: 728132, Serial Number(s):  EP16ER100003,EP16ER100004,EP16ER100005,EP16ER100007,EP16ER100008,EP16ER110003, EP16ER110004,EP16ER110005,EP16ER110006,EP16ER110007,EP16ER110008,EP16ER110009, EP16ER110010,EP16ER110011,EP16ER110012,EP16ER110013,EP16ER110014,EP16ER110015, EP16ER110016,EP16ER110017,EP16ER110018,EP16ER110019,EP16ER110020,EP16ER110021, EP16ER110022,EP16ER110023,EP16ER110024,EP16ER120001,EP16ER120002,EP16ER120003, EP16ER120004,EP16ER120005,EP16ER120006,EP16ER120007,EP16ER120008,EP16ER120009, EP16ER120010,EP16ER120011,EP16ER120012,EP16ER120013,EP16ER120015,EP16ER120016, EP16ER120017,EP16ER120018,EP16ER130001,EP16ER130002,EP16ER130003,EP16ER130004, EP16ER130005,EP16ER130006,EP16ER130007,EP16ER130008,EP16ER130009,EP16ER130010, EP16ER130011,EP16ER130012,EP16ER130013,EP16ER130014,EP16ER130015,EP16ER130016, EP16ER130017,EP16ER130018,EP16ER130019,EP16ER130020,EP16ER130021,EP16ER130022, EP16ER130023,EP16ER130024,EP16ER130025,EP16ER130026,EP16ER130027,EP16ER130028, EP16ER130029,EP16ER130030,EP16ER130031,EP16ER130032,EP16ER130033,EP16ER130034
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic Distribution: AR, CA, FL, GA, IL, IN, KY, MI, MS, NC, ND, NJ, NV, NY, OH, PA, PR, SC, TN, and VA. Foreign distribution: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Chile, China, Colombia, Congo, Ecuador, Egypt, France, Germany, Ghana, Greece, Gutamala, Hungray, India, Indonesia, Ireland, Italy, Japan, Jordan, Latvia, Lybyan Arab JHamahiri, Lithuania, Malawi, Mexico, Myanmar, Namibia, Nepal, Netherlands, Oman, Palestine, Paraguay, Philippines, Poland, Portugal, Romania,Russia, Rwanda, Saudi Arabia, Senegal, South Agrica, South ZKorea, Spain, Sri Lanka, Switzerland, Tunisia, Turkey, Uganda, UAE, Venezuela, Vietnam, Zambia.
  • Product Description
    MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients. Access Dual CT system can be used as a Head and Whole Body Computed Tomography X-ray System featuring a continuously rotating X-ray tube and detector array with multi-slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • Manufacturer Parent Company (2017)
  • Source
    USFDA